Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis (MAHALE)

NCT05006573 PHASE3 TERMINATED Results posted

This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation (NCFB+EI). All patients who complete the double-blind treatment period (28 to 52 weeks depending on the timing of patient randomization and when the revised CSP version 3.0 becomes effective) on investigational product (IP) may be eligible to continue into an open-label extension (OLE) period during which all patients will receive benralizumab. The revised OLE period is intended to allow patients approximately 32 weeks of treatment with open label benralizumab (24 weeks followed by a FU visit 8 weeks after the last dose of IP for a total of approximately 32 weeks).

Details

Lead sponsor	AstraZeneca
Phase	PHASE3
Status	TERMINATED
Enrolment	100
Start date	Wed Jul 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Non-cystic Fibrosis Bronchiectasis

Interventions

• Benralizumab
• Placebo to Benralizumab

Countries

Denmark, Italy, Russia, United Kingdom, Germany, Poland, South Korea, Philippines, Vietnam, Argentina, Canada, Australia, China, United States, Spain, India